Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
This study examines how certain risk factors (such as age, gender, other medical conditions, and the type of immunotherapy used to treat the cancer) affect whether a patient with a malignant solid tumor will develop mild or serious side effects from the immunotherapy medications. Immunotherapy is the type of treatment
| Condition(s) | Malignant Solid Neoplasm |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | This study examines how certain risk factors (such as age, gender, other medical conditions, and the type of immunotherapy used to treat the cancer) affect whether a patient with a malignant solid tumor will develop mild or serious side effects from the immunotherapy medications. Immunotherapy is the type of treatment that helps the body's immune system fight cancer. In the future, this information may help doctors make better decisions about cancer treatments. |
| Who can participate | Inclusion Criteria: * Participants must be planning to receive ICI-based therapy for a solid tumor malignancy. This therapy must be given according to Food and Drug Administration (FDA) label or National Comprehensive Cancer Network (NCCN) guidelines at Category 1 or 2A and not in the context of a clinical trial * Participants who have received prior ICI-based therapy must have completed ICI based therapy at least 180 days prior to registration * Participants must not have discontinued any prior ICI-based therapy (if applicable) because of irAE * Participants must not have received chemotherapy, biologic, or targeted-therapy within 21 days prior to registration * Participants must have recovered from side effects of prior therapy to the following standards per treating physician's discreti |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | SWOG Cancer Research Network |
| Locations | Anchorage, Alaska, United States; Anchorage, Alaska, United States; Anchorage, Alaska, United States; Anchorage, Alaska, United States; Anchorage, Alaska, United States; Anchorage, Alaska, United States (+843 more sites) |
| Start date | 2021-09-13 |
| NCT ID | NCT04871542 |
| Official listing | https://clinicaltrials.gov/study/NCT04871542 |